Parlodel 5mg capsules

  • Name:

    Parlodel 5mg capsules

  • Company:
    info
  • Active Ingredients:

    Bromocriptine Mesilate

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/12/18

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Summary of Product Characteristics last updated on medicines.ie: 21/12/2018

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Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

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1 - 0 of 97 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 21 December 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 December 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 21 January 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 21 January 2015 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.1: Information has been added with regards Parlodel not being recommended for the routine suppression of lactation or for relief of symptoms of post-partum pain and engorgement which can be adequately treated with non-pharmacological intervention

In section 4.2: A sub-heading of Posology has been added. Text has slightly changed with regards paediatric population and older people

In section 4.3: A contradiction has been added with regards suppression of lactation. Two contradictions have been removed; coronary artery disease and other severe cardiovascular conditions and symptoms and/or a history of serious physic disorders

In section 4.4: Reference to monitoring of blood pressure especially in the first few days of therapy has been added. Text in reference to elderly patients have changed to older people.

In section 4.6: Fertility has been added to the heading and as a sub-section

In section 4.8: Adverse reaction reporting statement has been added

In section 10: date of revision has changed

Updated on 21 January 2015 PIL

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.1: Information has been added with regards Parlodel not being recommended for the routine suppression of lactation or for relief of symptoms of post-partum pain and engorgement which can be adequately treated with non-pharmacological intervention

In section 4.2: A sub-heading of Posology has been added. Text has slightly changed with regards paediatric population and older people

In section 4.3: A contradiction has been added with regards suppression of lactation. Two contradictions have been removed; coronary artery disease and other severe cardiovascular conditions and symptoms and/or a history of serious physic disorders

In section 4.4: Reference to monitoring of blood pressure especially in the first few days of therapy has been added. Text in reference to elderly patients have changed to older people.

In section 4.6: Fertility has been added to the heading and as a sub-section

In section 4.8: Adverse reaction reporting statement has been added

In section 10: date of revision has changed

Updated on 12 June 2014 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.3: Long-term treatment: Evidence of cardiac valvulopathy is now contraindicated.

In section 4.4: Information regarding impulse control disorders has been added as a special warning and precaution. Further information regarding use in children and adolescents (aged 7 to 17) and the elderly has been added.

In section 4.8: Additional very rare psychiatric disorder adverse reactions have been added. Additional very rare cardiac disorder adverse reactions has been added. Additional warnings of impulse control disorders have been added to this section. Reporting of adverse reactions to the IMB have been added.

In section 4.9: Reported isolated reports of children ingesting Parlodel has been added to signs and symptoms of overdose

In section 10: Date of revision has changed to June 2014

Updated on 12 June 2014 PIL

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.3: Long-term treatment: Evidence of cardiac valvulopathy is now contraindicated.

In section 4.4: Information regarding impulse control disorders has been added as a special warning and precaution. Further information regarding use in children and adolescents (aged 7 to 17) and the elderly has been added.

In section 4.8: Additional very rare psychiatric disorder adverse reactions have been added. Additional very rare cardiac disorder adverse reactions has been added. Additional warnings of impulse control disorders have been added to this section. Reporting of adverse reactions to the IMB have been added.

In section 4.9: Reported isolated reports of children ingesting Parlodel has been added to signs and symptoms of overdose

In section 10: Date of revision has changed to June 2014

Updated on 26 July 2012 PIL

Reasons for updating

  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 10; the date of revision has changed to July 2012

Updated on 26 July 2012 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 10; the date of revision has changed to July 2012

Updated on 15 March 2011 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 7: the address of the MAH has changed
In section 10: the date of revision has changed to Feb 2011

Updated on 15 March 2011 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 7: the address of the MAH has changed
In section 10: the date of revision has changed to Feb 2011

Updated on 17 January 2011 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 1: The full name of the product is listed
In section 2: Addition of text 'For a full list of excipients, see section 1
In section 2; description of capsules have changed
In section 4.2: Additionally text added 'Initially half a tablet',
In section 4.4: Text has been removed in relation to pathological gambling etc
In section 4.8: Text has been removed in relation to class effects
In section 6.1: Composition of printing ink has changed
In section 6.3: shelf life has changed from 4 years to 3 years
In section 6.4: Addition storage precautions have been added
In section 7: Text 'Trading as' removed
In section 10: date of revision has changed

Updated on 17 January 2011 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 1: The full name of the product is listed
In section 2: Addition of text 'For a full list of excipients, see section 1
In section 2; description of capsules have changed
In section 4.2: Additionally text added 'Initially half a tablet',
In section 4.4: Text has been removed in relation to pathological gambling etc
In section 4.8: Text has been removed in relation to class effects
In section 6.1: Composition of printing ink has changed
In section 6.3: shelf life has changed from 4 years to 3 years
In section 6.4: Addition storage precautions have been added
In section 7: Text 'Trading as' removed
In section 10: date of revision has changed

Updated on 4 October 2007 SmPC

Reasons for updating

  • Change to marketing authorisation holder

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

MAH change from

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey  GU16 7SR

UK
 
to
 

Meda Health Sales Ireland Limited

Office 10, Dunboyne Business Park

Dunboyne

Co Meath

Ireland

 

Trading as:

 

Meda Pharma
 
Changed PA numbers from
PA 13/2/3
to
PA 1332/16/2
 
 

Updated on 4 October 2007 PIL

Reasons for updating

  • Change to marketing authorisation holder

Free text change information supplied by the pharmaceutical company

MAH change from

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey  GU16 7SR

UK
 
to
 

Meda Health Sales Ireland Limited

Office 10, Dunboyne Business Park

Dunboyne

Co Meath

Ireland

 

Trading as:

 

Meda Pharma
 
Changed PA numbers from
PA 13/2/3
to
PA 1332/16/2
 
 

Updated on 17 November 2005 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Updated on 17 November 2005 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 17 February 2005 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 17 February 2005 PIL

Reasons for updating

  • Change to section 10 - Date of revision of the text

Updated on 10 August 2004 SmPC

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 10 August 2004 PIL

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

Updated on 4 June 2003 PIL

Reasons for updating

  • New SPC for medicines.ie

Updated on 4 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)